FDA 510(k) Application Details - K250224

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K250224
Device Name	Powered Light Based Non-Laser Surgical Instrument
Applicant	iSMART Developments LTD 129 Green Lanes, Wylde Green Birmingham B73 5LT GB Other 510(k) Applications for this Company
Contact	Susan D'Arcy Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2025
Decision Date	04/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review